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CCRP Certified Clinical Research Professional (CCRP)

  • SOCRA
  • 4 free sample questions

About this exam

CCRP is the SOCRA exam Certified Clinical Research Professional (CCRP). Paid practice material for this exam is not available yet, but you can try its free sample questions.

Exam code
CCRP
Vendor
SOCRA
Practice questions
Not available yet
Free sample questions
4
Question bank last updated
Not available yet

Try 2 sample questions

Taken from the free sample set for CCRP.

Question 1

A coordinator for an ongoing industry-sponsored, multi-site Phase II clinical trial is taking an unexpected, long-term medical absence. The trial site retains coordinator services from an external source to support clinical trial activities. According to the ICH GCP Guideline, which of the following is responsible for implementing procedures to ensure the integrity of the clinical trial-related duties??

  1. Option A:
    The sponsor
  2. Option B:
    The investigator/institution
  3. Option C:
    The IRB/IEC
  4. Option D:
    The external source
Show answer and explanation

Correct answer: B

The investigator/institution bears responsibility for site conduct, oversight of delegated tasks, and ensuring qualified, trained staff—regardless of employment source. Exact extracts: ICH E6(R2) 4.1.1: “The investigator should be qualified… and have adequate resources to properly conduct the trial.” ICH E6(R2) 4.1.5: “The investigator should ensure that all persons assisting with the trial are adequately informed about the protocol, the investigational product(s), and their trial-related duties and functions.” ICH E6(R2) 4.2.5: “The investigator may delegate… but retains responsibility for the conduct of the trial at the site.” Therefore, the investigator/institution (B) must implement procedures and oversight to maintain integrity of trial duties. Reference: ICH E6(R2) Good Clinical Practice, §4.1.1; §4.1.5; §4.2.5 (Investigator responsibilities; delegation and oversight).

Question 2

During an internal compliance review, the site study team identified that a protocol-required blood sample collection was not obtained for a majority of the subjects enrolled. In accordance with the ICH GCP Guideline, the clinical investigator should:

  1. Option A:
    Suspend all trial-related activities until the events of the deviation have been mitigated
  2. Option B:
    Document and explain the deviation from the protocol
  3. Option C:
    Assign another investigator to perform sample collections until an internal investigation is completed
  4. Option D:
    Immediately report the observation to the regulatory authority
Show answer and explanation

Correct answer: B

ICH directs investigators to document and explain any deviation, with prompt reporting to IRB/IEC only when deviations are implemented to eliminate immediate hazards or as required. Exact extracts: ICH E6(R2) 4.5.3: “The investigator should document and explain any deviation from the approved protocol.” ICH E6(R2) 3.3.7 & 4.5.2 (paraphrased): deviations to eliminate immediate hazards must be reported as soon as possible. Here, absent immediate hazard, the required action is documentation and explanation (B). Reference: ICH E6(R2) Good Clinical Practice, §4.5.3 (Compliance with protocol; deviations). ICH E6(R2) §3.3.7; §4.5.2 (Reporting deviations implemented to eliminate immediate hazards).
See all 4 free sample questions